recombinant human thyroid stimulating hormone for radioiodine 131i treatment

Conditions: DTC - Differentiated Thyroid Cancer; Thyroid Stimulating; Hormone, C; Radiotherapy; Complications

Summary: subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer . experimental group: recombinant human thyroid stimulating hormone injection: 0.9mg/1.0ml/piece; intramuscular injection; once a day for two consecutive days. control group: thyroid hormone withdraw for 4-6 weeks. the two groups were treated with radioiodine 131i after plasma thyroid stimulating hormone elevated (\>30mu/l). the efficacy and adverse reactions were observed.


Eligibility criteria:
inclusion criteria: * age: 18\~75 years old (including 18 and 75 years old); * ecog: 0-2 points; * expected survival of more than 3 months; differentiated thyroid carcinoma undergoing total thyroidectomy or subtotal thyroidectomy and confirmed as locally recurrent or metastatic disease by imaging, serum tumor marker, biopsy pathology; at least one measurable lesion (diameter of the tumor ≥10 mm), and meets the requirements of recist 1.1. * hemoglobin ≥80g/l, neutrophil ≥1.5×109/l, platelet count ≥80×109/l, serum creatinine ≤1.5× upper limit of normal or creatinine clearance ≥60ml/min, blood urea nitrogen ≤2.5× upper limit of normal (uln); total bilirubin ≤1.5×uln; aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5×uln; if accompanied by liver metastasis, alt and ast≤5×uln albumin ≥25 g/l; * women of childbearing potential must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days prior to enrollment, with a negative result, and be willing to use appropriate contraceptive methods during the trial and for 1 year after the last dose of 131i (for women), or for 6 months after the last dose of 131i (for men); * participants voluntarily joined the study and signed informed consent, with good compliance and follow-up. exclusion criteria: * patients with severe and uncontrolled diseases, including: 1) uncontrolled hypertension (despite optimal drug therapy, systolic blood pressure ≥140mmhg or diastolic blood pressure ≥90mmhg); 2) poorly controlled arrhythmias of ischemic heart disease or myocardial infarction of grade ii or above (including corrected qt interval male ≥450 ms, female ≥470 ms) and ≥2 congestive heart failures (new york heart association classification); 3) poorly controlled diabetes (fasting blood sugar \&gt;10mmol/l); 4) active or poorly controlled severe infections (according to common terminology criteria for adverse events ≥ grade 2); 5) patients with active hepatitis b or hepatitis c (hepatitis b: positive hbsag and hepatitis b virus (hbv) dna ≥500 iu/ml; hepatitis c: positive hepatitis c virus rna and abnormal liver function), or active infections requiring antimicrobial therapy (e.g., with antibiotics, antiviral drugs, antifungal drugs); 6) renal insufficiency: urine routine shows urine protein ≥++ or confirmed 24-hour urine protein ≥1.0 g; 7) patients with seizures requiring treatment. * received surgical treatment, incisional biopsy, or major trauma within 28 days prior to randomization; * unable to quit or with a history of psychiatric medication abuse; * allergic to the investigational drug (recombinant human thyroid stimulating hormone or 131i) or its excipients; * had an infection within 4 weeks prior to screening, including bacterial, viral, or fungal infections, with ongoing symptoms at the time of screening; * received lipophilic iodine contrast agents (such as iodized oil, iodized benzene, etc.) within the past 3 months or received water-soluble iodine contrast agents (such as iohexol, iodinated glycerol, etc.) within the past 1 month prior to screening; * pregnant or lactating women, or women who engaged in unprotected sexual intercourse within the two weeks prior to screening, or women with a positive blood pregnancy test at screening; * male subjects (or their partners) or female subjects who have plans for fertility or donation of sperm or ova during the entire study period and within 6 months after the end of the study, and who are unwilling to adopt contraceptive measures during the study period and within 6 months after the end of the study; * researchers believe that the presence of any condition may harm the subjects or prevent them from meeting or fulfilling the study requirements.